Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh

NCT04344483 | Completed DMC

• 1 other identifier: 1506
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh. Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

Conditions

Non-healing Wound

Outcome Measures

Primary Outcomes (4)

• Intra operatieve bleeding

  Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.

  per operative

• Post operative bleeding

  post operative bleeding will be assesd in post operative period by number of dressings required.

  24 hours

• Post operative pain

  post operative pain will be assessed in the post operative period by visual analog score. Score ranges from 0 to 10 with 0 indicating no pain whereas 10 is worst pain.

  24 hours

• Analgesia requirement

  Post operative analgesia requirement of patient will be observed by number of medications required

  24 hours

Secondary Outcomes (1)

• Epithelization of donor site

  14 days

Study Arms (2)

Group A ( Lidocaine + Adrenaline)

ACTIVE COMPARATOR

Group A patients will receive 2% Lidocaine and 1:100,000 adrenaline soaked gauze over skin graft donor site of thigh per operatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site.

Drug: 2% Lidocaine and 1:100,000 Adrenaline

Group B ( Normal Saline)

PLACEBO COMPARATOR

Group B patients will receive normal saline soaked gauze over skin graft donor site of thigh intraoperatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site

Drug: Normal saline

Interventions

2% Lidocaine and 1:100,000 Adrenaline DRUG

Topical application of 2% Lidocaine and 1:100,000 Adrenaline in the form of dressing will be applied over skin graft donor site of thigh for 10 minutes.

Group A ( Lidocaine + Adrenaline)

Normal saline DRUG

Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.

Group B ( Normal Saline)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both the gender of age \> 15 years
• Multiple donor-sites

You may not qualify if:

• Bleeding disorder
• Concomitant injuries
• Donor site other than thigh
• Previously harvested donor-site
• Patients on antiplatelet medications

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Zaara Zahid

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (1)

• Gacto P, Miralles F, Pereyra JJ, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009 May;35(3):343-7. doi: 10.1016/j.burns.2008.06.019. Epub 2008 Oct 23.

  PMID: 18950945 RESULT

Related Links

• Gacto P, Miralles F, Pereyra J, Perez A, Martinez E. Haemostatic effects of adrenaline-lidocaine subcutaneous infiltration at donor sites. Burns. 2009;35(3):343-7.

MeSH Terms

Interventions

Lidocaine; Epinephrine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be recruited in the study by closed envelope technique and the study will be single blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Patients with non healing wound who will otherwise be healthy will be recruited in the study and will randomly assign groups. One group will receive Adrenaline and Lidocaine soaked gauze and the second group will be a control group who will receive normal saline soaked gauze.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: December 10, 2019
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

PA (1)